1. Field of the Invention
This invention relate to a composition of disaccharides that is useful for the non-invasive site-specific detection of gastrointestinal damage.
2. Related Background Art
Damage to the gastrointestinal tract can present a serious health risk. Therefore it is important to be able to locate the site of such damage within the gastrointestinal tract, i.e., the stomach, small intestine or colon, so that an appropriate treatment can be prescribed.
Stomach ulcers are one form of gastrointestinal damage which can pose a serious health threat as in many instances ulcers are asymptomatic. Since stomach ulcers can develop and be present without any symptoms the damage caused by the ulcers to the stomach and the bleeding associated with such ulcers presents a serious health risk which can be fatal. In the past, damage to the gastric epithelial cells was detected using endoscopies of the patients, x-ray examinations after ingesting a barium meal or through the introduction of a radio-labeled compound having an affinity for damaged epithelial cells. These treatments, however, are invasive or require the use of radioisotopes or x-rays.
PCT International Application No. WO92/00402 describes a non-invasive method for detecting gastric epithelial damage using a disaccharide such as sucrose, maltose or lactose which is orally administered to a patient followed by assaying the patient's blood or urine for the disaccharide to determine the existence and extent of gastric epithelial damage. While this advantageous method overcomes the problems associated with invasive or radioisotopic methods, it does not reliably detect damage of the intestinal tract.
Disorders to the small intestine and the colon also present significant health risks. Such disorders include, for example, carcinoma, benign lesions, Crohn's disease, colitis and the like. Cobden, I., et al., "Intestinal permeability and screening tests for coeliac disease", Gut, 21, 512-518 (1980) describes an assay for ascertaining damage to the small intestine using a combination of cellobiose and mannitol. However, this assay does not provide information on damage to the stomach or colon.
Meddings, J. B., et al., "Sucrose Permeability: A Novel Means Of Detecting Gastroduodenal Damage Noninvasively", Amer. J. Ther., 2(11), 843-849 (1995), disclose the use of a mixture of sucrose, lactulose and mannitol to show that increased sucrose permeability is a measure of damage to the stomach and not the small intestine. However, such a mixture does not provide a means of assaying the colon.
It would be desirable to provide a composition and method using such a composition for detecting site-specific gastrointestinal damage, i.e., the stomach, small intestine or colon, that is non-invasive and non-radioisotopic to alleviate both patient discomfort and the use, handling and disposal of radioactive isotopes. It would also be highly desirable to have such a site-specific gastrointestinal damage detection composition that could be readily used by practitioners in a simple setting (such as an office) to identify any damage to the gastrointestinal tract. Such a procedure would be helpful in the early diagnosis and thereby early treatment of a potentially serious condition.